DSMB ReportTHERATOPE(R) Vaccine Phase III Study Continuation Recommended by Data
Safety Monitoring Board
EDMONTON, May 14 /CNW/ - Biomira Inc. (Nasdaq: BIOM) (TSE: BRA)
announced
that an independent Data Safety Monitoring Board (DSMB) has reviewed
data from
approximately 800 patients in its pivotal Phase III trial with
THERATOPE(R)
vaccine. The DSMB recommendation was that the Company continues its
Phase III
study for metastatic breast cancer as planned. This is the DSMB's
third safety
review of the trial.
"Having reviewed the safety data, the DSMB feels the trial should
continue without any modifications," members of the DSMB stated.
"This continues the encouraging news from the DSMB and is another
milestone as the THERATOPE(R) vaccine study moves forward," commented Alex
McPherson, MD, PhD, President and CEO of Biomira. "Once again, our product
candidate is generally well-tolerated, and supports our confidence as
we move
towards potential regulatory approval."
The Phase III study completed enrolment of 1,030 women and is
ultimately
looking for at least 900 evaluable women. Women were enrolled at over 120
clinical sites in North America, the U.K., Europe, Australia and New
Zealand.
Final analysis of the trial data is expected to commence in mid-2003 with
possible submission in 2004. Interim analyses are planned to take
advantage of
the potential to make THERATOPE(R) vaccine available as soon as possible
should results of interim analyses support an earlier filing.
On May 3, 2001, Biomira announced a collaborative agreement with Merck
KGaA for the advancement of both THERATOPE(R) vaccine and BLP25
vaccine. BLP25
vaccine is currently being tested in Phase IIb trials for patients
with
non-small cell lung cancer.
Biomira is a biotechnology company specializing in the development of
innovative therapeutic approaches to cancer management. Besides
completion of
enrolment of the multinational Phase III trial with THERATOPE(R)
vaccine in
combination with Corixa's ENHANZYN(TM) adjuvant, Biomira is developing a
portfolio of complementary vaccine candidates, including BLP25 for
non-small
cell lung cancer, now in Phase IIb trials. The commitment to the
treatment of
cancer currently focuses on the development of synthetic vaccines and
novel
strategies for cancer immunotherapy. We are The Cancer Vaccine People(TM).
This release may contain forward-looking statements. Various factors
could cause actual results to differ materially from those projected in
forward-looking statements, including those predicting the timing of
clinical
trials, data evaluations and regulatory applications, the efficacy of
products
or the availability of capital. Although the Company believes that the
forward-looking statements contained herein are reasonable, it can give no
assurance that the Company's expectations are correct. All forward-looking
statements are expressly qualified in their entirety by this cautionary
statement.
/For further information: Biomira Company Contacts: Jane Tulloch,
Manager, Investor Relations, (780) 490-2812; Bill Wickson, Manager Public
Relations and Special Assistant, (780) 490-2818; Investor Relations:
Jonathan
Fassberg, The Trout Group, 212 477-9007 X16; Media Contact: Brad
Miles, BMC
Communications, 212 477-9007 X17;
To request a free copy of this organization's annual report, please go to
www.newswire.ca and click on reports@cnw./
(BRA. BIOM)